Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan

November 1, 2016 updated by: Hoffmann-La Roche

Registry on Post Menopausal Osteoporosis in Gynecology Setting in Pakistan (REPOSE)

This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

624

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan
      • Karachi, Pakistan
      • Karachi, Pakistan, 74800
      • Karachi, Pakistan, 74700
      • Lahore, Pakistan, 20021
      • Lahore, Pakistan
      • Lahore, Pakistan, 54550
      • Rawalpindi, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study will enroll gynecology outpatients in Pakistan who meet eligibility criteria for observation.

Description

Inclusion Criteria:

  • Postmenopausal women
  • Age 50 years or greater

Exclusion Criteria:

  • Previously diagnosed osteoporosis, or receiving treatment for osteoporosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study Population
Gynecology outpatients who meet eligibility criteria will be enrolled and evaluated for the presence of PMO at screening. Women diagnosed with PMO will complete an additional visit to document the prescribed management plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients diagnosed with PMO based upon dual-energy X-ray absorptiometry (DXA) results
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of various PMO treatment modalities
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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